EUS-guided choledochoduodenostomy (versus ERCP) for primary drainage of malignant distal biliary obstruction: a pilot study

Completed

• Conditions: Biliary obstruction (malignant); 10018008; 10004606; 10019818

• Registration Number: NL-OMON51255
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 21

Inclusion Criteria

- Radiographically (CT, EUS) distal malignant bile duct obstruction
- Histology or cytology proven malignancy of the primary tumour or metastasis;
onsite cytology evaluation after EUS guided fine-needle sampling that is highly
suspected of a malignancy suffices
- Indication for biliary drainage; in case of an resectable tumour this should
be discussed during a clinical multidisciplinary meeting
- Written informed consent

Exclusion Criteria

- Age < 18 year
- Surgically altered anatomy after previous gastric, periampullary or duodenal
resection
- Cancer extending into the antrum or proximal duodenum
- Extensive liver metastases
- WHO performance score of 4 (in bed 100% of time)
- Uncorrectable coagulopathy, defined by INR>1.5 or platelets < 50 x 109/L
- Clinically relevant gastric-outlet obstruction
- Unable to complete sign informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is technical success.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint are clinical success, procedural time, adverse events, stent<br /><br>patency, need for reinterventions, technical outcome at pancreaticoduodenectomy<br /><br>(when applicable), and cost.</p><br>